Associate Director of CMC - Quality Assurance

Job Responsibilities

• Member of CMC Development Teams providing Quality (QA) input from pre-clinical to end of product life cycle including NDA filing, other market filings, and post approval changes.
• Partners with technical SMEs to develop and approve the CMC strategy (DS, DP, and analytical strategy) for new drug candidates.
• Responsible for change control management for compound/product specific changes through the product lifecycle, including impact assessments, tracking, and implementation.
• Responsible Quality member for oversight and QA approver of all key Quality System deliverables associated with the drug development candidate, including proactive Initiatives, Deviations, Investigations, CAPAs, and Complaints.
• Review and approve compound/product specific analytical method life cycle documents (e.g., API and bulk drug product specifications, analytical test methods (including micro), and protocols/reports); including stability.
• Work with CMC Teams to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process.
• Communicate Quality risks within the Quality organization.
• Collaborate with Regulatory to track/own Quality input for ongoing regulatory filings and updates to Health Authorities (e.g., IND/IMPD/BLA/NDA), including specifications, shelf-life extensions, country-specific trial approvals, etc.
• Performs other tasks as assigned (e.g., final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations as required).

Education and Experience

• Minimum of B.S. degree, preferably in Chemistry, Biochemistry, or a similar Scientific field.
• Ten plus years of hands-on biologics/sterile experience within a development/operations facility (manufacturing and/or analytical).
• Prior experience in Quality is preferred.
• An equivalent combination of education and experience may be substituted.

Skills and Qualifications

• Thorough knowledge of the Pharmaceutical Development processes as evidenced by bringing multiple INDs through to successful BLA/NDA approval.
• Knowledge of bulk biologic drug substance (monoclonal antibody, bispecific, etc.), parenteral (cold chain liquid/lyophilized form) drug product, cell/gene therapy product process development/manufacturing, and/or development/manufacturing of radiopharmaceuticals is required.
• Recognized as a CMC expert, radiopharmaceuticals and/or biologics, with an ability to introduce best practices into the quality management systems.
• Thorough understanding of cGMPs and regulatory requirements (e.g., FDA, EU, ICH).
• Well-versed in relevant CMC area, with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.
• Excellent investigational and QA problem-solving skills.
• Analytical mindset, with an ability to assess new situations to define and implement the appropriate QA action plan.
• Apply AI to improve team execution and decision-making.
• Ability to work independently, yet effectively in a team environment.
• Superior attention to detail, excellent review skills and the ability to organize and manage multiple tasks in a fast-paced environment.
• Teamwork oriented with the ability to work effectively across functional groups and teams to ensure requirements are met (e.g., early phase, late phase, regulatory).
• Other proven competencies such as strategic thinker, influencer and negotiator are required.
• Continuous improvement mindset is also required.

Physical Demands

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision. This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.

Work Environment

The noise level in the work environment is usually moderate. Work-related travel (outside of Indianapolis, Indiana) may be required up to 20% of working time (e.g., 10 weeks per year).